Airway Clearance Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00379028
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : January 24, 2011
Information provided by:

Brief Summary:
The purpose of the study is to evaluate how the airways in COPD patients, compared to healthy volunteers, absorb steroid drugs from Symbicort Turbuhaler and Seretide Diskus. The blood concentrations of the steroids will be used as surrogate marker.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Budesonide/Formoterol Turbuhaler Drug: Salmeterol/Fluticasone Diskus Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Two-way Cross-over Study Evaluating Systemic Bioavailability and Airway Clearance of SymbicortTurbuhaler 320/9mcg vs SeretideDiskus 50/500mcg After Single Inhalations in Patients With COPD and Healthy Volunteers
Study Start Date : September 2006
Actual Study Completion Date : July 2007

Intervention Details:
    Drug: Budesonide/Formoterol Turbuhaler
    Other Name: Symbicort
    Drug: Salmeterol/Fluticasone Diskus

Primary Outcome Measures :
  1. Area under the curve (AUC) of the plasma concentrations of the steroid components 0 - 10 hours after study drug inhalation in patients with COPD and healthy volunteers

Secondary Outcome Measures :
  1. Exploratory investigations on the amount of steroids expectorated spontaneously in COPD patients
  2. Correlation between baseline lung function and AUC of steroids after inhalation.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • COPD patients: ≥40 years of age, Diagnosed COPD with symptoms ≥1 year, Pre-bronchodilatory FEV1 ≤55% of PN, Productive cough with expectoration.
  • Healthy volunteers: ≥18 years of age, Healthy, Pre-bronchodilatory FEV1 >80% of PN, Non-smoker

Exclusion Criteria:

  • COPD patients: Current respiratory tract disorder other than COPD, Asthma before 40 years of age, Significant or unstable cardiovascular disorder,
  • Healthy volunteers: Use of any regular medication or therapy, Pregnancy or breast-feeding,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00379028

Research Site
Lund, Sweden
United Kingdom
Research Site
Nottingham, United Kingdom
Sponsors and Collaborators
Study Director: Christer Hultquist, MD AstraZeneca
Principal Investigator: Tim Harrisson, MD Nottingham University

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00379028     History of Changes
Other Study ID Numbers: D5892C00012
EUDRACT 2006-002412-10
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol Fumarate
Salmeterol Xinafoate
Budesonide, Formoterol Fumarate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists